Quality Assurance Leader: Regulatory Compliance & CAPA

Allergan; Cincinnati (OH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a Quality Assurance Manager to lead QA across multiple manufacturing domains, ensuring compliance with FDA, EMA and ICH regulations. The role directs QA staff, develops policies, and interfaces with regulators during inspections.

The candidate will drive CAPA and improve quality metrics while guiding cross-functional teams to meet strategic objectives. The position requires a Bachelor's in a technical field and 8+ years in QA, with strong leadership, communication, and

Qualifications

• Bachelor's degree in a technical/scientific area (Chemistry, Pharmacy, Biology, Microbiology, Engineering) preferred.
• 8+ years in quality assurance or quality oversight or relevant experience.
• Leadership of professionals and cross-functional teams.

Responsibilities

• Provide QA support across manufacturing processes (pharma, devices, cosmetics, biologics).
• Translate strategy into tactical objectives and ensure compliance with regulations.
• Interface with FDA and other regulatory bodies during inspections.
• Review deviations and drive CAPA to reduce quality events.
• Communicate quality metrics to senior management and promote quality awareness.

Skills

Quality Assurance

Regulatory Knowledge

Quality Systems

CAPA

Leadership

Cross-functional Teams

FDA/Regulatory Compliance

Written Communication

Education

Bachelor's Degree in Chemistry/Pharmacy/Biology

Job description

AbbVie is seeking a Quality Assurance Manager to lead QA across multiple manufacturing domains, ensuring compliance with FDA, EMA and ICH regulations. The role directs QA staff, develops policies, and interfaces with regulators during inspections.

The candidate will drive CAPA and improve quality metrics while guiding cross-functional teams to meet strategic objectives. The position requires a Bachelor's in a technical field and 8+ years in QA, with strong leadership, communication, and